Ability to facilitate problem solving for defects that occur during manufacturing.
Provides expertise in manufacturing processes control for extrusion and injection molding components.
Audits and ensures manufacturing processes are in place to produce reliable products in a repeatable manner.
Conduct process audits and drive closure on improvement actions.
Coordinates development activities with Manufacturing and Engineering to help them in the process qualifications.
Coordinate all aspects of in-process inspections within cell(s), in-process inspections within cell(s), including training for long-term support of Six Sigma initiatives and compliance to ISO 13485, 14971, QSR, 21 CFR 820 and any other applicable standard or regulation.
Responsible for the Quality of all in-house manufactured parts.
Evaluate and determine disposition of non-conforming materials and formulate corrective actions.
Identify opportunities to improve manufacturing processes, e.g., lean techniques and optimized scale up.
Technical support of customers ensuring quality standards are understood, transferred appropriately and executed.
Internal coordination / liaison with engineering team to ensure appropriate control and introduction of any proposed changes to products and systems.
Provide process and quality support for manufacturing, validations, process improvement and productivity activities of new and existing projects and in-house qualifications.
Ensure synergy of quality initiatives with suppliers, internal processes and customer expectations.
Ability to analyze problems, identify root causes and provide efficient solutions.
Responsible for overseeing the IQ / OQ / PQ processing.
Proficient in Geometric Dimensioning & Tolerancing (GD&T) and blue print reading.
Ability to conduct and interpret Gage R&R studies.
Hand-on Metrology Experience for a wide variety of metrology tools.
Ability to teach and deploy new concepts to manufacturing, engineering and inspectors.
Ability to implement effective Sampling plans.
Strong problem solving, project management and communication skills.
Medical Device Injection Molding Background Preferred.
Experience in implementation of inspection sampling plans.
Good communication skills.
Ability to use Standard metrology tools for dimensional Inspection.
Bachelor of Science degree in Engineering or related science / technical field
1-3 years related experience and / or training working knowledge of 21CFR820 (quality systems regulation / good manufacturing practices for medical devices), ISO 13485 and 14971 standards.
Requires excellent organizational, communications and project management skills and the ability to work effectively in a multi-task environment.
Projects manage tactical day to day activities along with higher level projects.
Understanding and technical leadership and guidance with statistical techniques (i.e. sample size determination, DOE, Lean and Six Sigma process improvement techniques, etc.)
Knowledge and understanding of quality requirements for the medical device industry with general technical understanding of business operations.
Excellent verbal, written, analytical, computer and interpersonal skills with the ability to demonstrate lead capabilities with team approach, and sound decision making.
Organizational, prioritization, and presentation skills required.
Excellent interpersonal, communication, influencing, and facilitation skills.
Ability to work effectively cross functionally.
Required Skills / Abilities :
Bilingual (English / Spanish) 90-100% desired.
Assertive, Takes initiative, self starter, energetic, motivated and self managed.
Positive, Respectful, and Professional attitude.
Able to handle diverse activities simultaneously.
Works well in a team-oriented, cross-functional environment.
Ability to handle multiple tasks and operate in a fast-paced manufacturing environment.
Good reasoning abilities and sound judgment.
Proficiency in Microsoft Office applications, Excel in Particular.
Preferred Qualifications :
American Society for Quality CQE (Certified Quality Engineer) preferred but not required.
Experience with injection molding, silicone, and coating preferred.
Freudenberg Medical, part of the Freudenberg Group, is a global partner for the design, development and manufacture of innovative medical devices and components.
With 11 manufacturing operations and more than 1,500 associates worldwide, Freudenberg Medical offers a wide range of manufacturing capabilities from high precision molding and extrusion to drug coatings, finished devices, and subassemblies for catheters and minimally invasive devices.
For over 30 years, medical device and healthcare companies have trust Freudenberg Medical to manufacture their custom components and devices.
We operate FDA-registered, ISO 13485 certified medical device facilities with Class 7 & 8 cleanrooms. Design and manufacturing operations are located in the United States (California, Indiana, Massachusetts, Minnesota), Germany, Ireland, Costa Rica, and China.
Freudenberg Medical’s culture is positive and team oriented. In our environment we like to have fun while helping others with our cutting edge medical devices.
Our company is very driven to lead in the medical device industry to improve the quality of life of the patients we serve.
Freudenberg Medical is a local, innovative, high growth company with a collaborative, high performance work environment.
We develop and manufacture minimally invasive, single use medical devices in the endoscopy, cardiovascular, neurovascular, and urology markets.
The products we develop and manufacture are typically market disruptive and displace higher cost procedures.
We are currently hiring for a Quality Engineer who is :
Driven and focused on ensuring quality for all manufacturing cells in operations and New Business Activities
Striving to utilize statistical process controls to ensure a proactive ability to implement quality improvements
Able to demonstrate a sense of urgency and initiative on the manufacturing floor
Self-motivated and thrives in a fast paced, team-driven, lean systems environment, where every day brings new projects and challenges.
It’s an exciting time to work at Freudenberg Medical. We know our ability to succeed depends upon the people we employ. Leading-edge technology, the highest standards, and outstanding people make Freudenberg Medical the employer of choice in this industry.
We offer a competitive salary plus a full range of benefits including medical, dental and vision insurance, as well as 401K Match.